BENICAR HCT Drug Patent Profile
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When do Benicar Hct patents expire, and when can generic versions of Benicar Hct launch?
Benicar Hct is a drug marketed by Cosette and is included in one NDA.
The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Benicar Hct
A generic version of BENICAR HCT was approved as hydrochlorothiazide; olmesartan medoxomil by ALKEM LABS LTD on July 11th, 2024.
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Questions you can ask:
- What is the 5 year forecast for BENICAR HCT?
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Summary for BENICAR HCT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 94 |
| Clinical Trials: | 17 |
| Drug Prices: | Drug price information for BENICAR HCT |
| Drug Sales Revenues: | Drug sales revenues for BENICAR HCT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BENICAR HCT |
| What excipients (inactive ingredients) are in BENICAR HCT? | BENICAR HCT excipients list |
| DailyMed Link: | BENICAR HCT at DailyMed |
See drug prices for BENICAR HCT
Recent Clinical Trials for BENICAR HCT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| EMS | Phase 3 |
| Daiichi Sankyo Co., Ltd. | N/A |
| Chinese PLA General Hospital | Phase 4 |
Pharmacology for BENICAR HCT
| Drug Class | Angiotensin 2 Receptor Blocker Thiazide Diuretic |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Paragraph IV (Patent) Challenges for BENICAR HCT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BENICAR HCT | Tablets | hydrochlorothiazide; olmesartan medoxomil | 20 mg/12.5 mg | 021532 | 1 | 2007-05-11 |
| BENICAR HCT | Tablets | hydrochlorothiazide; olmesartan medoxomil | 40 mg/12.5 mg and 40 mg/25 mg | 021532 | 1 | 2007-02-15 |
US Patents and Regulatory Information for BENICAR HCT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-002 | Jun 5, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for BENICAR HCT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-002 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-002 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BENICAR HCT
See the table below for patents covering BENICAR HCT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 0115516 | ⤷ Sign Up | |
| Norway | 332938 | ⤷ Sign Up | |
| Ireland | 920540 | ⤷ Sign Up | |
| Norway | 20032261 | ⤷ Sign Up | |
| China | 1698603 | ⤷ Sign Up | |
| European Patent Office | 0503785 | Dérivés de 1-biphénylimidazole, leur préparation et leur utilisation thérapeutique (1-Biphenylimidazole derivatives, their preparation and their therapeutic use) | ⤷ Sign Up |
| Australia | 2002214324 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BENICAR HCT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0503785 | C00503785/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: SANKYO COMPANY LIMITED, JP |
| 0503785 | 91330 | Luxembourg | ⤷ Sign Up | CERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS) |
| 0503785 | 300133 | Netherlands | ⤷ Sign Up | 300133, 20120221, EXPIRES: 20170220 |
| 0503785 | CA 2006 00012 | Denmark | ⤷ Sign Up | |
| 0502314 | SPC/GB02/037 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
| 0503785 | C300133 | Netherlands | ⤷ Sign Up | PRODUCT NAME: OLMESARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN DE CARBOXYGROEP GEKOZEN UIT DE VOLGENDE : EEN ALKYLGROEP 1-4 KOOLSTOFATOMEN, EEN BENZYLGROEP, EEN ALKANOYLOXYALKYLGROEP WAARIN HET ALKANOYLDEEL 1-5; NATL. REGISTRATION NO/DATE: RVG 28785-RVG 28787 20030527; FIRST REGISTRATION: DE 502.02.00.00,502.02.01.00, 502.02.02.00 20020813 |
| 0454511 | 99C0009 | Belgium | ⤷ Sign Up | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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